BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PDT, Inc.

    DI: 00813677021557 · Model: R287 G3 Thin Composite · PDT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PDT, Inc.
    Primary DI
    00813677021557
    Version / Model
    R287 G3 Thin Composite
    Catalog Number
    R287
    Company Name
    PDT, INC.
    Labeler DUNS
    125850144
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-04-30
    Public Version
    2
    Public Version Date
    2022-05-17
    Public Version Status
    Update
    Public Device Record Key
    c928d876-ac67-425b-b9c2-ce7285b01e73

    Device Description

    G3 Thin Composite

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    EKH Carver, Dental Amalgam, Operative

    GMDN Terms

    Code Name
    35793 Dental restoration carver, amalgam, reusable

    Identifiers

    Type ID
    Primary 00813677021557